Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective ED Headache Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00313703
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : May 9, 2011
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Brief Summary:
The purpose of this study is to determine how often headaches recur and to learn how to predict continued suffering from headache after emergency department discharge.

Condition or disease
Headache

Detailed Description:

The majority of the 5 million people who arrive at Emergency Departments (ED) with a headache every year are suffering from an acute exacerbation of a chronic, recurrent headache disorder. The role of the ED in treating these patients has been ill-defined. Often emergency physicians will treat the acute exacerbation and will not attend to the natural history of the disease. However, about two thirds of primary headache patients will suffer a recurrent headache in the 24 hours after discharge from the ED. And, many patients will continue to suffer recurrent headaches for months after their ED discharge.

The purpose of this study is to learn how often headaches recur and to try to find a way to predict who will have a recurrent headache after ED discharge.

After standard ED treatment for headache, participants in the study will be asked to answer questions about prior headaches and medical history, and some census-like questions about race/ethnicity, salary, and education via a 20-minute interview with a research associate. The researchers will follow-up with 10-minute telephone calls to each participant's home in 24 hours and in 3 months with additional questions. Total length of time for study participation is approximately 40 minutes.


Layout table for study information
Study Type : Observational
Actual Enrollment : 477 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache
Actual Study Start Date : March 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache




Primary Outcome Measures :
  1. Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge [ Time Frame: 24 hours after Emergency Department (ED) discharge ]
    Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain


Other Outcome Measures:
  1. Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal [ Time Frame: 3 months ]
    Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample of ED patients
Criteria

Inclusion Criteria:

  • Emergency Department patients who present primarily for headache.
  • Need to consent to and be available for follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313703


Locations
Layout table for location information
United States, New York
Montefiore Medical Center, 111 East 210th Street
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Benjamin Friedman, MD, MS Department of Emergency Medicine, Montefiore Medical Center

Layout table for additonal information
Responsible Party: Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00313703     History of Changes
Other Study ID Numbers: 04-03-077E
First Posted: April 12, 2006    Key Record Dates
Results First Posted: May 9, 2011
Last Update Posted: May 15, 2018
Last Verified: April 2018

Keywords provided by Benjamin W. Friedman, MD, Montefiore Medical Center:
headache
emergency department
migraine
recurrent headache

Additional relevant MeSH terms:
Layout table for MeSH terms
Headache
Pain
Neurologic Manifestations
Signs and Symptoms